Delivering tAN to Reduce HMB: The LUNA Study

Recruiting N/A Interventional Study
Heavy Menstrual Bleeding
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
14 – 45
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Spark Biomedical, Inc. · Industry
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About This Trial
The LUNA study is a prospective, randomized, double-blind, sham-controlled, decentralized clinical trial in participants with heavy menstrual bleeding of no known structural cause. The study includes two age-based cohorts: adolescents aged 14-21 and adults aged 22-45. Participants in both cohorts will be randomized to receive transcutaneous auricular neurostimulation (tAN), which targets the auric…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Regularly menstruating female aged 14-45 years at time of screening 2. History of menorrhagia as assessed by the Menorrhagia Screening Tool 3. Stable/consistent use of current non-hormonal medications and supplements for the past three months, willingness to continue use for …
Contacts

Laura Mitchell

(844) 534-9716

LUNA@lindushealth.com

CONTACT

Caroline Benner

(210) 624-8046

clinicaltrials@sparkbiomedical.com

CONTACT